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Botanix Pharmaceuticals (ASX:BOT) submits new FDA application for sofpironium bromide

ASX News, Health Care
ASX:BOT      MCAP $921.9M
26 September 2022 11:10 (AEDT)

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Botanix Pharmaceuticals (BOT) has submitted a new drug application (NDA) to the FDA for the commercial sale of its sofpironium bromide gel.

The gel is designed to treat primary axillary hyperhidrosis, which Botanix said affected over seven million people in the US alone.

The company said it was targeting FDA approval for the product in the fourth quarter of 2023, provided the application followed a typical 12-month assessment and review period.

The submission follows successful results from Botanix’s phase three trials of the product, which demonstrated “highly statistically significant clinical efficacy and excellent safety”.

Moreover, the product has already been approved for sale in Japan, with “outstanding” early sales already achieved.

Botanix President and Executive Chair Vince Ippolito said the FDA submission was a milestone for the company.

“Approximately 7.3 million people in the US suffer from hyperhidrosis and have the potential to benefit from sofpironium bromide,” Mr Ippolito said.

“We look forward to working closely with the FDA on the approval of sofpironium bromide.”

The company said looking ahead, it now planned to pursue other opportunities to bolster its product pipeline with additional late-stage or revenue-producing dermatology products.

Earlier this month, the company raised $7.5 million via a share placement to fund the costs associated with the sofpironium bromide FDA filing.

Shares in Botanix were up 6.45 per cent to 6.6 cents at 11:01 am AEST.

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